의약품유해사롿�보고를 통한 아��피프라졸의 실마리정보 검색 및 안전성정보 개발 (Signal Detection and Safety Information Generation of Aripiprazole in Spontaneous Adverse Event Reports Database)

본 연구는 비정형 항정신병제인 아��피프라졸에 대하여 국내 유해사례보고 자료를 토대로 실마리정보를 검색하고 평가하여 안전성정보를 생산하고자 실시하였다. 한국의약품안전관리원에서 구축한 의약품유해사롿�보고 데이터베이스로부터1989년부터 2012년까지 2,565건의 아��피프라졸-유해사례조합을 추출하였고, PRR, ROR, IC값을 활용한 데이터마이닝기법 및 우선순위화 알고리즘을 사용하여 78개의 실마리정보를 검색하였다. 이 중 국내 허가사항에 반영되어 있지 않은 20개의 유해사례에 대해 국외 허가사항 및 문헌을 검토하는 등 실마리정보 평가과정을 거쳐 안전성정보를 생산하였다.
아��피프라졸에 대한 최종 안전성정보로는 등통증, 코피, 건성안, 사정장애가 있었고, 이는 2013년 4월 식품의약품안전처의 조치로 국내 허가사항의 주의사항에 반영되었다.

ObjectivezzKorea Institute of Drug Safety and Risk Management works for signal detection and safety information generationby analyzing spontaneous adverse event reports database. As the number of reports and detected signals of aripiprazoleby each data mining indices were more than other drugs, aripiprazole was selected as a subject of study.
Methodszz1989–2012 spontaneous reporting database was analyzed and the model drug ingredient was aripiprazole. Weestimated proportional reporting ratio, reporting odds ratio, and information component for data mining. Then we assessedthe causality through review of local and foreign drug labels and literatures.
ResultszzIn reconstructed 1989–2012 spontaneous reporting database, there were 2,062 reports on aripiprazole and 2,565aripiprazole-adverse events pairs. As a result of data mining analysis and signal prioritization, 78 adverse events were detected,20 adverse events of them were not included in drug label. After literature review, back pain, epistaxis, xerophthalmiaand ejaculation disorder were generated as novel safety information on aripiprazole.
ConclusionzzThose 4 novel safety informations of Aripiprazole, back pain, epistaxis, xerophthalmia and ejaculation disorderhad become listed on the local label in April 2013.